Eye Safety Filter, Two-Position (532 nm)

GUDID 00813125014520

For use on the Zeiss Dovetails OD3 @ 532 nm

IRIDEX CORPORATION

General/multiple surgical diode laser system
Primary Device ID00813125014520
NIH Device Record Keyd2ca7db1-dfa0-4f23-af19-fb4a2d6b513f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEye Safety Filter, Two-Position (532 nm)
Version Model Number65475
Company DUNS612920785
Company NameIRIDEX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com
Phone(800) 388-4747
Emailtechsupport@iridex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813125014520 [Primary]

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-30
Device Publish Date2024-10-22

On-Brand Devices [Eye Safety Filter, Two-Position (532 nm)]

00813125014520For use on the Zeiss Dovetails OD3 @ 532 nm
00813125014513For use on the Leica or Wild Dovetails OD3 @ 532 nm
00813125010270For use on the Zeiss Dovetails OD3 @ 532 nm
00813125010263For use on the Leica or Wild Dovetails OD3 @ 532 nm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.